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Dose effects of the gonadotropin-releasing hormone antagonist, Nal-Glu, combined with testosterone enanthate on gonadotropin levels in normal men.

AbstractOBJECTIVE:
To test the hypothesis that over a 4-week treatment period, Nal-Glu GnRH antagonist ([AcD2Nal1, D4ClPhe2, D3Pal3, Arg5, DGlu6 [AA], DAla10] GnRH) at a dose of 200 micrograms/kg per day SC would suppress levels of immunologically active and biologically active LH and FSH more completely than a dose of 100 micrograms/kg per day.
DESIGN:
Placebo controlled clinical study.
SETTING:
A university community.
SUBJECTS:
Thirty normal male volunteers.
INTERVENTIONS:
We administered Nal-Glu at doses of 0, 100, and 200 micrograms/kg body weight per day in combination with T enanthate, 50 mg IM weekly, to separate groups of men (9 or 10 men per group) for 4 weeks.
RESULTS:
Serum levels of immunologically active and biologically active gonadotropins were suppressed similarly in both groups of men who received Nal-Glu; this suppression was significantly greater than in the men who received placebo + T. Local side effects were more severe in the Nal-Glu 200 micrograms/kg per day group.
CONCLUSIONS:
Administration of Nal-Glu in combination with T suppresses gonadotropins more completely than does T alone, but at doses > 100 micrograms/kg, gonadotropins are not suppressed additionally with larger doses of Nal-Glu. Subjects experienced greater local discomfort and side effects with the higher dosage. These findings suggest that dosages of Nal-Glu of > 100 micrograms/kg per day may have no advantage over the 100-micrograms/kg dose in a male contraceptive regimen.
AuthorsC J Bagatell, J E Rivier, W J Bremner
JournalFertility and sterility (Fertil Steril) Vol. 64 Issue 1 Pg. 139-45 (Jul 1995) ISSN: 0015-0282 [Print] United States
PMID7789550 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Gonadotropins
  • LHRH, N-Ac-2-Nal(1)-4-Cl-Phe(2)-3-Pal(3)-Arg(5)-Glu(6)-AlaNH2(10)-
  • Gonadotropin-Releasing Hormone
  • Testosterone
  • testosterone enanthate
  • Luteinizing Hormone
Topics
  • Adult
  • Biological Assay
  • Dose-Response Relationship, Drug
  • Drug Synergism
  • Fluoroimmunoassay
  • Gonadotropin-Releasing Hormone (adverse effects, analogs & derivatives, antagonists & inhibitors, pharmacology)
  • Gonadotropins (blood)
  • Humans
  • Luteinizing Hormone (blood)
  • Male
  • Radioimmunoassay
  • Testosterone (analogs & derivatives, blood, pharmacology)

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